Label: PANOXYL- benzoyl peroxide soap
- NDC Code(s): 11118-0264-4
- Packager: The Original Bradford Soap Works Inc
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated June 2, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
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When using this product
- skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.
- skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
- avoid unnecessary sun exposure and use a sunscreen
- avoid contact with the eyes, lips and mouth
- avoid contact with hair and dyed fabrics, which may be bleached by this product
- Stop use and ask a doctor if
- If pregnant or breast feeding
- Keep out of reach of children
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Directions
- clean the skin thoroughly before applying this product
- work into a lather
- cover the entire affected area with a thin layer and rinse thoroughly one to three times daily
- pat dry
- because excessive drying of the skin may occur, start with one application daily, then graudally increase to two or three times daily if needed or as directed by a doctor
- if bothersome dryness or peeling occurs, reduce application to once a day or every other day
- if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop ise of both products and ask a doctor.
- Other information
- Inactive ingredients
- Warnings
- Use
- PanOxyl® Acne Treatment Bar
- Package label
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INGREDIENTS AND APPEARANCE
PANOXYL
benzoyl peroxide soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11118-0264 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 12.6 g in 113 g Inactive Ingredients Ingredient Name Strength ICODEXTRIN (UNII: 2NX48Z0A9G) 17.6 g in 113 g WATER (UNII: 059QF0KO0R) 10.8 g in 113 g DECYL GLUCOSIDE (UNII: Z17H97EA6Y) 2.7 g in 113 g CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) 13.2 g in 113 g TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY) 0.4 g in 113 g SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.5 g in 113 g SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493) 52.2 g in 113 g GLYCERIN (UNII: PDC6A3C0OX) 3 g in 113 g Product Characteristics Color Score Shape OVAL (Saddle) Size 91mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11118-0264-4 113 g in 1 CARTON; Type 0: Not a Combination Product 06/05/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M006 06/05/2023 Labeler - The Original Bradford Soap Works Inc (001201045)
